U.S. patent number 5,702,019 [Application Number 08/534,754] was granted by the patent office on 1997-12-30 for vial having resealable membrane assembly activated by a medical delivery device.
This patent grant is currently assigned to Becton Dickinson France S.A.. Invention is credited to Jean Pierre Grimard.
United States Patent |
5,702,019 |
Grimard |
December 30, 1997 |
Vial having resealable membrane assembly activated by a medical
delivery device
Abstract
A resealable assembly for a container such as a bottle or vial
featuring a membrane for selectively opening or sealing a fluid
path between the bottle and a medical delivery device introduced
into the assembly. The assembly includes a body disposed on said
bottle, and a luer connector hub which may be separately provided
with the body or formed integrally therewith. The luer connector
hub features a connector end open for access by the medical
delivery device, and an opposed end which is disposed for fluid
communication with the open top of the bottle. A membrane,
preferably formed from an elastomeric material, is secured across
both the opposed end of the luer connector hub and the open top of
the bottle, and may be retained between the top surface of the
bottle and the body. The membrane preferably includes a central
area sealing the opposed end of the luer connector hub from the
open top of the bottle, with one or more fluid openings defined on
a portion of the membrane outside of the central area. A force
exerted on the central area by the medical delivery device deflects
the membrane towards the interior of the vial, urging the membrane
from sealing contact with the body and, hence, opening the fluid
path between the interior of the bottle and the medical delivery
device. The central area may display one or more fluid flow
channels to facilitate fluid flow between the medical delivery
device and the bottle as contact is made between the medical
delivery device and the central area of the membrane. A sealing rib
may be provided around a portion of the periphery of the luer
connector hub to enhance sealing contact between the membrane and
the luer connector hub.
Inventors: |
Grimard; Jean Pierre (Vif,
FR) |
Assignee: |
Becton Dickinson France S.A.
(LePont de Claix, FR)
|
Family
ID: |
24131396 |
Appl.
No.: |
08/534,754 |
Filed: |
September 27, 1995 |
Current U.S.
Class: |
215/301; 141/24;
141/319; 141/349; 141/383; 215/274; 215/302; 215/304; 215/DIG.3;
220/203.11; 604/91 |
Current CPC
Class: |
A61J
1/2096 (20130101); Y10S 215/03 (20130101); A61J
1/2037 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); A61M 037/00 (); B65D 041/50 ();
B65D 045/30 () |
Field of
Search: |
;215/301,299,307,310,231,329,270,275,302,350,DIG.3
;220/367.1,368,254,203.07,203.11,203.15-17
;604/411,412,413,414,415,416,89,90,91 ;128/760
;141/23,24,26,27,312,319,349,350,383,386 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0 406 374 B1 |
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Dec 1990 |
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EP |
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1071487 |
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Mar 1954 |
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FR |
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1487413 |
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May 1967 |
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FR |
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3618158A1 |
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Mar 1987 |
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DE |
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501 172 |
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Feb 1971 |
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CH |
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WO 95/3841 |
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Feb 1995 |
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WO |
|
Primary Examiner: Shoap; Allan N.
Assistant Examiner: Kopsidas; Naki M.
Attorney, Agent or Firm: Castiglione; Vincent A.
Claims
I claim:
1. A resealable container assembly accessible by a medical delivery
device and providing a resealable fluid path between the medical
delivery device and the container, comprising:
a container having an open top and a top surface disposed around
portions of the container surrounding said open top;
a body disposed adjacent the top surface of the container;
means for communicating fluids with the container, said means
having an end configured for introduction of the medical delivery
device and an opposed end disposed on said body; and
a membrane disposed between the open top of said container and the
opposed end of the means for communicating, said membrane having a
central area disposed for contact with the medical delivery device
and having a width at least equal to the width defined by the
opposed end of the means for communicating, said central area
comprising at least one fluid flow channel, said membrane having at
least one fluid passage located outside said central area for fluid
communication, via said at least one fluid flow channel between the
medical delivery device introduced into the means for communicating
and the open top of the container, and said membrane defining a
sealing portion between said central area and said at least one
fluid passage for sealing contact with the body,
wherein upon contact between said medical delivery device and the
central area, said membrane is displaced to an open position,
wherein said membrane is urged away from said sealing contact with
the body to open the fluid path between the medical delivery device
and the container.
2. The reseatable container assembly of claim 1, wherein said means
for communicating comprises a luer connector hub.
3. The resealable container assembly of claim 2, further comprising
an external seal for sealing the connector end of the luer
connector hub.
4. The resealable container assembly of claim 3, wherein said
external seal comprises a luer connector seal having a top wall and
an annular side wall projecting from said top wall, said annular
side wall including an array of internal threads selectively
engageable with the connector end of said luer connector hub, and a
seal disposed between said top wall and the connector end of the
luer connector hub for sealingly engaging said connector end.
5. The resealable container assembly of claim 2, wherein said at
least one fluid passage comprises a slit.
6. The resealable container assembly of claim 1 wherein said at
least one fluid flow channel comprises spaces defined between
raised protrusions provided on said central area.
7. The resealable container assembly of claim 1, wherein said at
least one fluid flow channel comprises one or more troughs formed
on the surface of the central area.
8. The resealable container assembly of claim 1, further comprising
a sealing rib disposed about at least a portion of the periphery of
said opposed end of the means for communicating, said sealing rib
disposed for said sealing contact with said membrane when said
membrane is in the closed position.
9. The resealable container assembly of claim 8, wherein when said
medical delivery device displaces said membrane to the open
position, said membrane is urged from sealing contact with said
sealing rib to create a gap between the membrane and the sealing
rib, thereby opening the fluid path between the medical delivery
device and the open top of the container.
10. The resealable container assembly of claim 8, wherein said
sealing rib comprises a rib having a square cross-section.
11. The resealable container assembly of claim 8, wherein said
sealing rib comprises a rib having a peaked cross-section.
12. The resealable container assembly of claim 8, wherein said
sealing rib comprises a rib having a rounded cross-section.
13. The resealable container assembly of claim 1, wherein said body
and said means for communicating are formed as a unitary
component.
14. The resealable container assembly of claim 1, wherein said body
and said top surface are formed as a unitary component.
15. The resealable container assembly of claim 14, wherein said
membrane comprises an elastomeric element supported between said
body and the top surface of the bottle.
16. The reseatable container assembly of claim 1, wherein said
membrane comprises an elastomeric element.
17. The reseatable container assembly of claim 1, wherein said
membrane comprises an elastomeric element supported between said
body and the top surface of the container.
18. The resealable container assembly of claim 1, further
comprising a plurality of sealing ribs disposed about at least a
portion of the periphery of said opposed end of the means for
communicating for sealing contact with said membrane in the closed
position.
19. The resealable container assembly of claim 1, further
comprising a sealing rib disposed on said membrane for contact with
said body outside of the periphery of the opposed end of the means
for communicating.
20. The resealable container assembly of claim 1, wherein the
container comprises an annular rim disposed about the open top of
the container, said annular rim defining said top surface.
21. The resealable container assembly of claim 20, further
comprising a crimp cap for securing said body to said annular
rim.
22. The resealable container assembly of claim 1, wherein said at
least one fluid passage comprises an opening.
23. The resealable container assembly of claim 1, wherein said body
comprises a portion insertable through the open top of the bottle,
said membrane comprising an elastomeric element extended across the
opposed end of the means for communicating and the open top of the
bottle.
24. A resealable container assembly accessible by a medical
delivery device and providing a resealable fluid path between the
medical delivery device and the container, comprising:
a bottle having an open top and a top surface disposed around
portions of the container surrounding said open top;
a body disposed adjacent the top surface of the container;
a luer connector hub for communicating fluids with the container,
said luer connector hub having a connector end configured for
introduction of the medical delivery device and an opposed end
disposed on said body, a plurality of ribs provided about the
periphery of the opposed end; and
a membrane disposed between the open top of said container and the
opposed end of the means for communicating, said membrane having a
central area disposed for contact with the medical delivery device
and having a width at least equal to the width defined by the
opposed end of the means for communicating, said membrane having at
least one fluid passage located outside said central area for fluid
communication between the medical delivery device introduced into
the luer connector hub and the open top of the container, and said
membrane defining a sealing portion between said central area and
said at least one fluid passage for sealing contact with the
plurality of ribs provided on the opposed end of the luer connector
hub,
wherein upon contact between said medical delivery device and the
central area, said membrane is displaced to an open position,
wherein said membrane is urged away from sealing contact with the
body to open the fluid path between the medical delivery device and
the container.
25. A resealable container assembly accessible by a medical
delivery device and providing a resealable fluid path between the
medical delivery device and the container, comprising:
a bottle having an open top and a top surface disposed around
portions of the container surrounding said open top;
a body disposed adjacent the top surface of the container;
a luer connector hub for communicating fluids with the container,
said luer connector hub having a connector end configured for
introduction of the medical delivery device and an opposed end
disposed on said body; and
a membrane disposed between the open top of said container and the
opposed end of the means for communicating, said membrane having a
central area disposed for contact with the medical delivery device
and having a width at least equal to the width defined by the
opposed end of the means for communicating, said membrane having at
least one fluid passage located outside said central area for fluid
communication between the medical delivery device introduced into
the luer connector hub and the open top of the container, and said
membrane defining a plurality of sealing ribs between said central
area and said at least one fluid passage for sealing contact with
the body,
wherein upon contact between said medical delivery device and the
central area, said membrane is displaced to an open position,
wherein the plurality of sealing ribs of said membrane are urged
away from sealing contact with the body to open the fluid path
between the medical delivery device and the container.
Description
FIELD OF THE INVENTION
The invention relates to a vial having a resealable membrane
assembly, and more particularly, to a vial having a resealable
membrane assembly activated by a medical delivery device for
efficient transfer of fluid to or from the vial.
BACKGROUND
Dry drugs such as powdered or lyophilized drugs are typically
stored in sealed vials. In practice, the drug is accessed shortly
prior to use by rupturing or piercing the seal. A solvent solution
such as saline is then introduced into the vial to reconstitute the
powdered or lyophilized drug. Once reconstituted, the drug solution
is extracted from the vial for use.
Some prior art vials of powdered or lyophilized drugs include a
pierceable membrane secured across the open top of the prior art
vial. The membrane is normally pierced by a needle in communication
with the solvent. However, care must be taken to avoid the
separation of membrane fragments when the seal is pierced, as these
may be accidentally delivered to the patient. Typically, these
seals must be pierced each time access to the solvent is desired,
heightening the problems associated therewith.
Other prior art vials include rubber stoppers that are either
removed from or urged into the vial when delivering the solvent for
reconstituting the drug. While in general these assemblies work
well to safely store the drug prior to use, one drawback of these
stoppers is that they cannot be accessed after they have fallen
into the vial. Hence, the vial cannot be reseated employing the
stopper originally provided. Accordingly, the structure of these
prior art vials is not readily adapted to a vial capable of
repeated opening or closing. Where a practitioner may not desire or
need to administer the entire dose of reconstituted drug held in
the vial, the vial would typically need to be resealed against the
ambient environment to preserve the sterility of the drug remaining
in the vial.
The stopper employed with a particular drug is typically formulated
from a material compatible with the drug held in the vial. While
the stopper normally poses no harm to the safety of the
reconstituted drug, there may be a perception--however flawed--that
the presence of the stopper in the interior of the vial somehow
adversely affects the drug held therein. Also, there may be the
perception that the presence of the stopper in the vial may
interfere with the subsequent flow of the drug solution.
SUMMARY OF THE INVENTION
A resealable assembly for a vial or bottle is provided for
resealable fluid access to and from the interior of the vial or
bottle. The assembly establishes a resealable fluid path between a
medical delivery device for introducing into, or aspirating out of
the bottle, fluids, and permits a practitioner repeated access to
the drug held in the bottle while at the same time preserving its
sterility.
The bottle includes an interior, an open top in fluid communication
with the interior, and a top surface disposed around portions of
the bottle surrounding the open top. The top surface may be formed,
for instance, as an annular rim around the open top.
The resealable assembly features a body disposed on the top surface
of the bottle. A fluid access device is disposed on the body to
provide fluid access to and from the interior of the bottle. In one
embodiment, the fluid access device is configured as a luer
connector hub. The luer connector hub includes a connector end
configured for access by a component of a medical delivery device,
and an opposed end disposed for fluid communication with the open
top of the bottle. If desired, the body and the luer connector hub
may be provided as separate components, or they may be integrally
formed as one component.
The connector assembly further includes a membrane disposed between
the open top of the bottle and the opposed end of the luer
connector hub. The membrane may be supported between the body and
the top surface of the bottle. The membrane may be held in place,
for instance, by an annular clip retaining the body to the top
surface of the bottle. If desired, the body and the top surface of
the bottle may be formed as an integral component, with the
membrane secured in the integral component so as to be disposed
between the opposed end of the luer connector hub and the open top
of the bottle.
The membrane, which may be formed from an elastomeric material such
as various thermoplastic elastomers, natural or synthetic rubbers,
or the like, preferably includes a central area disposed for
contact with the medical delivery device introduced into the luer
connector hub. The central area also features a width at least
equal to the width defined by the opposed end of the luer connector
hub. One or more fluid openings are preferably disposed on the
membrane outside the central area. The openings form part of the
resealable, fluid path between the open top of the bottle and the
medical delivery device.
One or more sealing ribs may be disposed on the body about the
periphery of the opposed end of the luer connector hub. The sealing
ribs preferably are disposed for sealing contact with the membrane
in a location between the central area and the one or more
openings. If desired, the sealing ribs may be provided on the
membrane itself. The membrane is displaceable between a sealing
position, wherein the membrane is disposed for sealing contact with
the body to close the fluid path, and an open position, wherein the
membrane is urged away from the body to open the fluid path. If
desired, one or more fluid channels may be defined in the central
area of the membrane to facilitate fluid flow between the medical
delivery device and the membrane as the membrane is displaced by
the medical delivery device into its open position.
If desired, a luer lock seal may be provided which is threadably
engageable with the connector end of the luer connector hub. The
luer lock seal prevents inadvertent access to the interior of the
bottle until use is ultimately desired. Also, if desired, a
protective cap may be fitted about the exterior of the bottle to
protect the luer connector hub. The cap may be affixed with a
tamper-evident seal, as is conventional.
In use, the luer lock seal (if provided) is removed by the
practitioner, so that the connector end of the luer connector hub
is disposed for access by the medical delivery device. The medical
delivery device may feature a male luer tip which is insertable
through the connector end of the luer connector hub. The male luer
tip will exert a force against the central area of the membrane,
such that the membrane will be displaced into its open position.
The membrane will be displaced from its sealing contact with the
sealing ribs, thereby creating a gap between the membrane and the
sealing ribs. Fluid flow is thereby permitted between the medical
delivery device and the interior of the bottle via the one or more
channels formed in the central area of the membrane and, via the
one or more openings in the membrane, the fluid path between the
open top of the bottle and the medical delivery device. Upon
removing the medical delivery device from contact with the central
area, the membrane will re-deflect towards its closed position,
such that the membrane will be redisposed for sealing contact with
the fibs, closing the fluid path.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will now be described in greater detail by way of
reference to the appended drawings, wherein:
FIG. 1 is a blow-up view in perspective of a resealable bottle
assembly affixed to a bottle containing therein a drug, with a
medical delivery device such as a a syringe employed to deliver to
the drug;
FIG. 2 is a cut-away view depicting one embodiment of a resealable
bottle assembly in accordance with the present invention;
FIG. 3 is another cut-away view of the resealable bottle assembly
of FIG. 2, illustrating displacement of the membrane to its open
position by action of the medical delivery device, thereby opening
the fluid path between the medical delivery device and the open top
of the bottle;
FIG. 4 is another cut-away view of the resealable bottle assembly
of FIG. 2, illustrating resealing of the membrane;
FIG. 5 depicts one embodiment of the membrane illustrated in FIGS.
2-4;
FIG. 5a illustrates a variant of the membrane illustrated in FIG.
5;
FIG. 6 is a partial cut-away view of the resealable bottle assembly
of FIG. 2, illustrating the membrane in its open position and the
relationship between the luer tip and the central area of the
membrane;
FIG. 7 is another partial cut-away view of the resealable bottle
assembly of FIG. 2, as viewed along line 7--7 of FIG. 6;
FIG. 8 is an exploded perspective view of the resealable bottle
assembly depicted in FIGS. 2-7;
FIG. 9 depicts a rimless bottle employable with the resealable
bottle assembly of the present invention;
FIG. 10 illustrates unitary manufacture of a body and bottle, and
retention of the membrane therein, in accordance with the present
invention;
FIGS. 11a-11c depict various alternative configurations for the
sealing rib;
FIGS. 12a-12d depict various structures for enhancing retention of
the membrane between the body and the stop surface of the bottle;
and
FIG. 13 illustrates an alternate manner of supporting the
membrane.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
While the description and figures herein makes reference to a vial
or bottle, it will be understood and appreciated by the skilled
artisan that any type of container normally employed in the field
of endeavor, such as capsules, jars or like vessels are readily
amenable to the advantages described herein. In addition, while
herein described with regard to containers having a quantity of dry
drug or medicament for reconstitution by liquid obtained from an
external source, it will be appreciated by the skilled artisan that
the invention is not so limited. For instance, the invention may be
applied to containers holding therein a quantity of liquid
medication, wherein repeated access is desired.
Turning now to the drawings, wherein like numerals depict like
components, FIGS. 2-10 depict an embodiment 20 of a resealable
bottle assembly in accordance with the present invention, and FIG.
1 is an exploded perspective view of resealable bottle assembly 20
mounted to a bottle or vial 10 containing therein a drug 16. Drug
16 may entail, for instance, a medicament in powdered or granular
form, such as a lyophilized medicament, intended to be
reconstituted by a fluid introduced into vial 10 by a medical
delivery device such as syringe 60. Alternately, it will be
appreciated by the skilled artisan that drug 16 may entail a fully
liquid medicament to which repeated access by the practitioner is
desired.
Syringe 60 may feature, for instance, a male luer tip 62 for
introducing fluid into the interior of bottle 10 via a luer
connector hub 32 associated with the resealable bottle assembly 20,
as will be more fully described herein. Syringe 60 may also display
a luer lock collar 64 surrounding luer tip 62. Internal portions of
luer lock collar 64 may include a thread 65 engageable with an edge
35 associated with luer connector hub 32. While syringe 60 is
herein depicted as a luer lock syringe, it will be evident to the
skilled artisan that the invention is equally amenable to luer slip
syringes. It will also be evident to the skilled artisan that
syringe 60 may serve to aspirate reconstituted drug 16 from bottle
10.
As will be evident from the various drawings, bottle 10 may include
a neck portion 13 defining an open top 12 with a width "X". Bottle
10 further preferably includes a top surface 14 disposed around
open top 12. In the configuration depicted herein, top surface 14
is defined by an uppermost portion of an annular rim 15 formed
around open top 12 of the bottle. It will be realized by the
skilled artisan that the top surface of the bottle may also be
established by rings or other means attached about open top 12 of
the bottle.
Turning now to FIGS. 2-10, resealable bottle assembly 20 features a
relatively flat body 22. Body 22 may be formed separate from bottle
10, and attached to top surface 14 of the bottle by securing the
body to annular rim 15 with a crimp cap 48. It will also be evident
to the skilled artisan that in lieu of a body separately supplied,
body 22 may be unitarily formed with bottle 10. For instance, body
22 may define a contiguous extension of annular rim 15.
Resealable bottle assembly 20 includes means for communicating with
bottle 10, fluids either supplied by a medical delivery device such
as syringe 60 or which will be aspirated out of bottle 10. Such
means for communicating may take many forms, and need not be
restricted to any one type of structure. For example, the means for
communicating fluids can be formed as a needle transfer assembly as
taught, for instance, in U.S. Pat. No. 5,358,501. As here depicted,
the means for communicating fluids is provided as a luer connector
hub 32. Other means will be envisioned by the skilled artisan.
The luer connector hub features a connector end 34 configured for
access by luer tip 62 of the syringe, and an opposed end 36 located
on body 22 adjacent open top 12 of the bottle. As illustrated in
FIG. 2, opposed end 36 of the luer connector hub may define a width
"A" less than the width "X" of open top 12 of the bottle. For
purposes which will be hereinafter more fully described, a sealing
rib 30 is preferably provided about the periphery of opposed end 36
of the luer connector hub. Sealing rib 30 may be formed as part of
body 22, or it can form an extension of opposed end 36 of luer
connector hub 32.
It will be apparent to the skilled artisan that luer connector hub
32 may be supplied separately from body 22 and affixed thereto, for
instance, by adhesives, welding, or like affixation methods.
Likewise, it will be realized by the skilled artisan that, if
desired, luer connector hub 32 may be unitarily formed with body
22.
Resealable bottle assembly 20 preferably features a membrane 40
which is displaceable between an open position (FIGS. 3, 6, 7) and
a closed position (FIGS. 2, 4) relative to body 22. As will be
herein described, when the membrane is disposed in its open
position, a fluid path 54 is established between luer tip 62 and
open top 12 of the bottle, permitting free fluid flow between
syringe 60 and the interior of bottle 10. Likewise, fluid path 54
is closed when membrane 40 is returned to its closed position,
preventing fluid flow through luer connector hub 32, and isolating
the interior of bottle 10 from the ambient environment.
As depicted in FIGS. 2-7, membrane 40, which may be formed from an
elastomeric material such as various thermoplastic elastomers,
natural or synthetic rubbers, or the like, can be configured in a
roughly cylindrical, planar manner. Membrane 40 includes an edge 46
securable between body 22 and top surface 14 of the bottle, for
instance, by the force exerted by crimp cap 48. Membrane 40
preferably includes a central area 42 having a width "N" at least
equal to width "A" of opposed end 36 of the luer connector hub.
Membrane 40 is actuated into its open position (FIGS. 3, 6, 7) when
luer tip 62 is inserted through open end 34 of the luer connector
hub for contact with central area 42 of the membrane. Thus, when
the membrane is secured to bottle 10, central area 42 is disposed
fully across the opposed end of luer connector hub 32.
Various structures may be incorporated to assist in the retention
of membrane 40 between body 22 and the top surface of the bottle.
For instance, ribs 46a (FIG. 12a) may be incorporated onto edge 46
to provide extra grip between body 22 and annular rim 15. Likewise,
ribs 23 and/or ribs 15a (FIG. 12b) may be incorporated on the body
and/or the annular rim, respectively, for the same purpose.
Alternately, as seen in FIG. 12c, membrane 40 may include a flap
247 which is locked beneath annular rim 15 by the action of crimp
cap 48. Likewise, the membrane might include a portion 249 wedged
into a slot 25 defined in body 22 (FIG. 12d), enhancing the
gripping action of the crimp cap. Other variations will be
envisioned by the skilled artisan.
Fluid passages are provided on membrane 40 to enable fluid
communication between the open top of the bottle and the opposed
end of the her connector hub. In one configuration, the fluid
passages are configured as one or more openings 44 preferably
defined on membrane 40 outside of central area 42. Openings 44 form
part of fluid path 54 when membrane 40 is disposed in its open
position. The one or more openings 44 are located on membrane 40
such that when the membrane is disposed in its closed position
(FIGS. 2 and 4), sealing rib 30 will contact the membrane in a
sealing area 43 located around the membrane between central area 42
and the one or more openings, sealing luer connector hub 32 from
fluid communication with open top 12 of the bottle, hence closing
fluid path 54. It will also be realized that membrane 40 may be
designed or otherwise formed from an appropriate material such that
when the membrane is in its closed position, the one or more
openings 44 will rest flush against body 22 (as is illustrated in
FIG. 4), further sealing the luer connector hub from fluid
communication with the open top of the bottle.
It will be realized by the skilled artisan that in lieu of openings
44, the fluid passages may be realized as pre-pierced slits 44a or
pinpoint type punctures 44b (See FIG. 5a) formed or otherwise
provided through membrane 40. Slits 44a or punctures 44b are
configured such that when membrane 40 is disposed in its open
position, the slits/punctures will be stretched open to provide
fluid access between the open top of the bottle and the luer
connector hub. Likewise, when the membrane is disposed in its
closed position, slits 44a or punctures 44b will close, thereby
providing a self-sealing ability to enhance the sealing provided by
rib 30.
To facilitate fluid flow between luer tip 62 and open top 12 of the
bottle, one or more fluid channels 45 may be provided on central
area 42. Fluid channels 45, if provided, form part of fluid path 54
openable between luer tip 62 and open top 12 of the bottle. As
herein depicted, fluid channels 45 may entail spaces that are
defined between ribs 47 formed on the central area. Fluid channels
45 effectively communicate fluid supplied or aspirated via luer tip
62 with portions of membrane 40 outside of central area 42.
Resealable bottle assembly 20 may further include an external seal
70 for preserving the sterility of the various components,
inclusive of drug 16, pending use. In one configuration, seal 70
features a circular end wall 72, and a cylindrical side wall 74
with an internal thread 76 configured for threadably engaging edge
35 provided with connector end 34 of the luer connector hub. A
suitable sealing material 78, such as a rubber seal, may be secured
to the interior face of circular end wall 72. Accordingly, seal 70
can be threadedly engaged onto luer connector hub 32 and tightened
such that sealing material 78 sealingly engages open connector end
34 of the luer connector hub. Thus, a barrier is established
against the passage of contaminants or other unwanted material
through connector end 34 of the luer hub which (if otherwise
uncovered), would provide communication through the luer connector
hub and, potentially, through open top 12 of bottle 10.
When a practitioner desires to introduce fluid to drug 16 held
within bottle 10, luer lock seal 70 may be removed by unscrewing
same from connector end 34 of the luer connector hub. Connector end
34 is thus exposed for insertion of luer tip 62 of syringe 60 (see
FIGS. 3, 6, 7). By manual force exerted by a user upon syringe 60
or, when structure is provided, by threadedly engaging luer lock
collar 64 with edge 35 of the luer connector hub, luer tip 62 is
urged into contact against ribs 47 formed on central area 42 of the
membrane. It will be seen that luer tip 62 thus urges membrane 40
towards the interior of bottle 10, displacing the membrane to its
open position. A gap 61 having a width "C" is created between
sealing rib 30 and central area 42. With the opening of gap 61,
fluid path 54 is completed between the luer tip and the interior of
the bottle 10. Via fluid path 54, fluid flow is fully enabled
between syringe 60 and the interior of the bottle via: luer tip 62;
fluid channels 45; gap 61; and the one or more openings 44 provided
in membrane 40.
A practitioner may now advance a plunger (not shown) associated
with syringe 60, thereby supplying fluid to the interior of bottle
10. Thereafter, keeping fluid path 54 open by maintaining the
connection between syringe 60 and luer connector hub 32, the
practitioner may re-aspirate the now reconstituted drug 16 into
syringe 60, causing the reverse fluid flow--i.e., drug 16 may flow
into syringe 60 via: the one or openings 44; gap 61; fluid channels
45; and luer tip 62. The drug 16 is thus ready for administration
by the practitioner, as desired.
Where it is not desired or necessary to utilize all of drug 16 held
within bottle 10, the practitioner may simply reseal bottle 10 by
disengaging syringe 60 from luer connector hub 32. As exemplified
by FIG. 4, by removing the force exerted by luer tip 62 upon
central area 42 of the membrane, membrane 40 will resiliently
deflect upwards towards its closed position. Luer connector hub 32
will be sealed from open top 12 of the bottle via sealing
engagement between membrane 40 and sealing rib 30. Fluid path 54
will thus be closed, isolating the interior of bottle 10 from
exposure with the ambient environment, thereby preserving the
sterility of any drug 16 still remaining within the bottle. Also,
as previously explained, depending upon the design and resiliency
characteristics of membrane 40, openings 44 will also be disposed
for contact with body 22, further preventing inadvertent fluid flow
between luer connector hub 32 and open top 12 of the bottle, and
helping to isolate drug 16 from the ambient environment.
Various features of either of the resealable bottle assembly may be
configured in alternate manners. For example, sealing rib 30 is
depicted herein with a squared cross-section. However, it will be
apparent to the skilled artisan that the sealing ribs may also
display a rounded (FIG. 11a) cross-sections, peaked or pointed
(FIG. 11b) cross-sections, or any suitable configuration ensuring
sealing contact between rib 30 and membrane 40. Moreover, while for
ease of illustration a single sealing rib 30 has been shown, it
will be apparent that more than one concentric sealing rib (FIG.
11c) may be disposed about the periphery of opposed end 36 of the
luer connector hub.
If desired, it will be apparent to the skilled artisan that in lieu
of a sealing rib 30 formed with the body or as an extension of the
luer connector hub, a sealing rib 200 may be formed as part of the
structure of membrane 40 itself (see FIG. 6). Sealing rib 200 may
be located between the one or more openings 40 and central area 42.
Thus, rib 200 will be urged into sealing contact with body 22 when
membrane 40 returns to its closed position.
The various components associated with the luer connector hub, the
pusher or the body may be molded or otherwise formed from medical
grade plastics, glass, or like materials. Similarly, bottle 10 may
be either plastic or glass, as is conventional.
The principles of the invention are equally applicable to a rimless
bottle 10', where a top surface 14' may be encompassed by the
uppermost area of wall 11 surrounding open top 12' (see FIG. 9).
Here, membrane 40 and body 22 are directly affixed to top surface
14', for instance, by welding, adhesives, or mechanical methods of
affixation.
It will also be evident to the skilled artisan that if, as
previously described, body 22 and bottle 10 are unitarily formed,
membrane 40 may be formed with them, for instance, by a suitable
co-injection process. Likewise, as depicted in FIG. 10, if membrane
40 is supplied separately from a unitarily formed bottle 10"/body
22", membrane 40" may be secured across the interface between
opposed end 36 of the her connector hub and open top 12" of the
bottle, for instance, by supporting edges 46" of membrane 40" in a
gap or annulus 17" defined by the unitary bottle 10"/body 22".
Moreover, it will be realized that the membrane need not be secured
between the body and the top surface of the bottle. For instance,
the membrane could be associated with the body itself and engaged
across the open top of the bottle, for instance, by being secured
in the neck of the bottle. FIG. 13 illustrates an embodiment 200 of
the resealable bottle assembly substantially as hereinbefore
described albeit configured to retain the membrane against the neck
of the bottle. A body 222 is provided, having a downwardly
extending portion 222b that is in fluid communication with a luer
connector hub 232 substantially as previously described. Downwardly
extending portion 222b is configured for insertion into neck
portion 213 of bottle 210. Membrane 240 includes an annular bead
248 retained between neck portion 213 and a complementary groove
260 formed on downwardly extending portion 222b. One or more
annular ribs 249 may also be provided on membrane 240 distal of
annular bead 248. While body 222 may be secured to annular rim 215
via a crimp cap, as here shown, body 222 is threadedly secured to
annular rim 215 via complementary threads 228, 226 formed on the
annular rim and sidewall 227 of the body, respectively. As in the
previously described embodiments, membrane 240 rests between the
bottom end of luer connector hub 232 (via downwardly extending
portion 222b) and the open top of the bottle for opening and
closing of the fluid path. It will be realized that by this
configuration, annular bead 248 and, if provided, the one or more
annular ribs 249, may also act as a stopper for bottle 210.
It will be appreciated and understood by those skilled in the art
that further and additional forms of the invention may be devised
without departing from the spirit and scope of the appended claims,
the invention not being limited to the specific embodiments
shown.
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